Germany's drug gatekeeper spurns Shire's new ADHD drug Elvanse

The German price watchdog has found yet another drug it can't warm up to. This time it's Shire's new ADHD drug Vyvanse, known as Elvanse in Germany.

The Institute for Quality and Efficiency in Health Care (IQWiG) decided that Shire ($SHPG) could not show that Elvanse provided any additional benefit compared to existing treatments. The agency said Shire's comparison study was too short and didn't look at the drug as part of a comprehensive treatment program. "This was neither sensible nor did it comply with the approval," the agency wrote. "An added benefit of lisdexamfetamine is therefore not proven."

Under budget cuts in Germany, IQWiG was given the responsibility of assessing new treatments in comparison with existing alternatives. The agency's decisions determine whether new drugs can bear premium price tags. And that is undercut if IQWiG decides treatments aren't superior to older drugs. "No additional benefit" is the catch phrase.

Shire, of course, has lots of company. Sanofi's ($SNY) new diabetes drug Lyxumia was tagged as having "no additional benefit" in June. Pfizer's ($PFE) lung cancer treatment Xalkori and the Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) diabetes drug Komboglyze both got an initial thumbs-down from IQWiG in February. Sometimes the agency allows drugmakers to come back with more data to prove their cases.

Shire has been doing well anyway with Vyvanse, which is the successor to its blockbuster Adderall XR. Generics of that drug hit the market not that long ago. But Vyvanse last year broke the $1 billion blockbuster ceiling itself after turning in 28% growth for the year.